Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women living in Tororo, Uganda, an area of high malaria transmission. HIV-infected pregnant women between 12 and 28 weeks gestation will be randomized to receive enhanced malaria chemoprevention with monthly dihydroartemisinin-piperaquine (DP) versus monthly DP placebo. Their HIV-exposed children will receive the same prevention regimen from 2 to 24 months of age to which the mothers were randomized. All women will receive daily trimethoprim-sulfamethoxazole (TS) throughout the study per Uganda Ministry of Health guidelines. Children will also receive daily TS from 6 weeks to 24 months of age. TS will be considered a study drug only in infants and children beginning 6 weeks after cessation of breastfeeding and upon exclusion of HIV infection. Women and their children will be followed for 36 months after delivery. In a subset of the study population, the investigators will conduct an intensive pharmacokinetic study that will evaluate pharmacokinetic exposure of DP and EFV. The investigators will also measure HIV-related outcomes among the women enrolled in the study. The investigators will test the hypothesis that for HIV-infected mothers and HIV-exposed infants, that enhanced versus standard malaria chemoprevention in HIV-infected pregnant women and their children will reduce the incidence of malaria among children from 0 to 24 months of age and improve the development of naturally acquired antimalarial immunity.
Pregnant women will be scheduled to be seen in the study clinic every 4 weeks during their pregnancy. Women will be seen at 1 week, 6 weeks, and 3 months postpartum and every 3 months thereafter. In addition, pregnant women will be instructed to come to the study clinic for all their medical care and avoid the use of any outside medications. Women will be provided all routine HIV care at the clinic according to Uganda MOH guidelines. All women will have ARVs and TS dispensed at the study clinic. Counseling on breastfeeding and infant feeding will be provided per Uganda MOH guidelines. HIV care and breastfeeding and infant feeding recommendations may be changed to reflect the most recent standard of care per MOH guidelines. Children will be scheduled to be seen in the clinic every 4 weeks and parents /guardians of children will be instructed to bring their child to the study clinic for all medical care and avoid the use of any outside medications. The study clinic will remain open 7 days a week from 8 a.m. to 5 p.m.
Each time a study participant is seen in the clinic a standardized history and physical exam will be performed. Patients who are febrile (tympanic temperature > 3 8.0ËšC) or report history of fever in the past 24 hours will have blood obtained by finger prick for a thick blood smear. If the thick blood smear is positive, the patient will be diagnosed with malaria. If the thick blood smear is negative, the patient will be managed by study physicians for a non-malarial febrile illness. If the patient is afebrile and does not report a recent fever, a thick blood smear will not be obtained, except when following routine testing schedules.
Routine assessments will be done in the clinic every 4 weeks for both pregnant women and children. Pregnant women and children will receive standards of care as designated in the Uganda MOH guidelines. Children will have care for HIV-exposed children according to MOH guidelines, with the exception that TS will be continued until 2 years of life. Routine care in children will use Integrated Management of Childhood Illness (IMCI) guidelines. During routine assessments subjects will be asked about visits to outside health facilities and the use of any medications outside the study protocol. Standardized assessment of adherence will also be done for study drugs administered at home and Insecticide Treated Net use. A routine history and physical exam will be performed using a standardized clinical assessment form. Blood will be collected by finger prick for thick smear, collection of plasma for PK studies, and filter paper samples. Phlebotomy for routine laboratory tests (CBC and ALT) to monitor for potential adverse events from study medications and for immunology studies will be performed every 8 weeks in pregnant women. Non malaria screening will also include stool ova and parasite examination, circulating filarial antigens (by ICT card for Wucheria), and blood smear for microfilaremia (including Mansonella perstans) using Knott's technique. For pregnant women, study drugs will be administered at the time of each routine visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily TS + Monthly DP pregnancy | Active Comparator | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily. |
|
| Daily TS + DP Placebo pregnancy | Placebo Comparator | Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Placental Malaria | The primary outcome will be the prevalence of placental malaria based on placental histopathology and dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence of placental infection. | at delivery estimated to be within 10 to 30 weeks of study entry |
| Incidence of Malaria, Pregnant Women | The primary outcome will be the incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. | Time at risk will begin following administration of first dose of study drug to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Parasitemia at Delivery by Microscopy and LAMP | Proportion of women with parasitemia detected by microscopy or LAMP at delivery | At delivery |
| Placental Parasitemia (Number of Women With Placental Blood Samples Positive for Malaria by Microscopy or PCR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Diane V Havlir, MD | University of California, San Francisco | Principal Investigator |
| Grant Dorsey, MD, PhD | University of California, San Francisco | Principal Investigator |
| Moses R Kamya, MBChB, MMed, PhD | Makerere University; Infectious Diseases Research Collaboration | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDRC Research Clinic - Tororo District Hospital | Tororo | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28187497 | Background | Kajubi R, Huang L, Jagannathan P, Chamankhah N, Were M, Ruel T, Koss CA, Kakuru A, Mwebaza N, Kamya M, Havlir D, Dorsey G, Rosenthal PJ, Aweeka FT. Antiretroviral Therapy With Efavirenz Accentuates Pregnancy-Associated Reduction of Dihydroartemisinin-Piperaquine Exposure During Malaria Chemoprevention. Clin Pharmacol Ther. 2017 Sep;102(3):520-528. doi: 10.1002/cpt.664. Epub 2017 May 30. | |
| 27821443 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TS + DP Placebo Pregnancy | Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily. Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines. Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Monthly placebo + daily trimethoprim/sulfamethoxazole (TS) | Drug |
|
Proportion of placental blood samples positive for malaria by microscopy or PCR |
| At delivery |
| Number of Monthly Routine Visits With Positive Blood Samples for Parasites | Proportion of monthly routine blood samples positive by LAMP for parasites | Following administration of first dose of study drug to delivery |
| Composite Adverse Birth Outcome (Proportion With Low Birth Weight (<2500 gm), Spontaneous Abortion (<28 Weeks), Stillbirth (Fetal Demise ≥28 Weeks), Congenital Anomaly, or Preterm Delivery (<37 Weeks) | Proportion with low birth weight (<2500 gm), spontaneous abortion (<28 weeks), stillbirth (fetal demise ≥28 weeks), congenital anomaly, or preterm delivery (<37 weeks) | At delivery |
| Number of Routine Visits Measured Every 8 Weeks During Pregnancy for Which the Participants Had Anemia | Anemia (hemoglobin less than 11g/dL) measured every 8 weeks during pregnancy | Following administration of first dose of study drugs to delivery |
| Background |
| Sonoiki E, Nsanzabana C, Legac J, Sindhe KM, DeRisi J, Rosenthal PJ. Altered Plasmodium falciparum Sensitivity to the Antiretroviral Protease Inhibitor Lopinavir Associated with Polymorphisms in pfmdr1. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e01949-16. doi: 10.1128/AAC.01949-16. Print 2017 Jan. |
| 28329368 | Result | Natureeba P, Kakuru A, Muhindo M, Ochieng T, Ategeka J, Koss CA, Plenty A, Charlebois ED, Clark TD, Nzarubara B, Nakalembe M, Cohan D, Rizzuto G, Muehlenbachs A, Ruel T, Jagannathan P, Havlir DV, Kamya MR, Dorsey G. Intermittent Preventive Treatment With Dihydroartemisinin-Piperaquine for the Prevention of Malaria Among HIV-Infected Pregnant Women. J Infect Dis. 2017 Jul 1;216(1):29-35. doi: 10.1093/infdis/jix110. |
| 28480292 | Result | Prahl M, Jagannathan P, McIntyre TI, Auma A, Wamala S, Nalubega M, Musinguzi K, Naluwu K, Sikyoma E, Budker R, Odorizzi P, Kakuru A, Havlir DV, Kamya MR, Dorsey G, Feeney ME. Sex Disparity in Cord Blood FoxP3+ CD4 T Regulatory Cells in Infants Exposed to Malaria In Utero. Open Forum Infect Dis. 2017 Feb 11;4(1):ofx022. doi: 10.1093/ofid/ofx022. eCollection 2017 Winter. |
| 27614925 | Result | Odorizzi PM, Feeney ME. Impact of In Utero Exposure to Malaria on Fetal T Cell Immunity. Trends Mol Med. 2016 Oct;22(10):877-888. doi: 10.1016/j.molmed.2016.08.005. Epub 2016 Sep 7. |
| 27717402 | Result | Prahl M, Jagannathan P, McIntyre TI, Auma A, Farrington L, Wamala S, Nalubega M, Musinguzi K, Naluwu K, Sikyoma E, Budker R, Vance H, Odorizzi P, Nayebare P, Ategeka J, Kakuru A, Havlir DV, Kamya MR, Dorsey G, Feeney ME. Timing of in utero malaria exposure influences fetal CD4 T cell regulatory versus effector differentiation. Malar J. 2016 Oct 7;15(1):497. doi: 10.1186/s12936-016-1545-6. |
| 29029337 | Result | Roh ME, Shiboski S, Natureeba P, Kakuru A, Muhindo M, Ochieng T, Plenty A, Koss CA, Clark TD, Awori P, Nakalambe M, Cohan D, Jagannathan P, Gosling R, Havlir DV, Kamya MR, Dorsey G. Protective Effect of Indoor Residual Spraying of Insecticide on Preterm Birth Among Pregnant Women With HIV Infection in Uganda: A Secondary Data Analysis. J Infect Dis. 2017 Dec 19;216(12):1541-1549. doi: 10.1093/infdis/jix533. |
| 39324693 | Derived | Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3. |
| 33020153 | Derived | Hughes E, Imperial M, Wallender E, Kajubi R, Huang L, Jagannathan P, Zhang N, Kakuru A, Natureeba P, Mwima MW, Muhindo M, Mwebaza N, Clark TD, Opira B, Nakalembe M, Havlir D, Kamya M, Rosenthal PJ, Dorsey G, Aweeka F, Savic RM. Piperaquine Exposure Is Altered by Pregnancy, HIV, and Nutritional Status in Ugandan Women. Antimicrob Agents Chemother. 2020 Nov 17;64(12):e01013-20. doi: 10.1128/AAC.01013-20. Print 2020 Nov 17. |
| 30530597 | Derived | Wallender E, Zhang N, Conrad M, Kakuru A, Muhindo M, Tumwebaze P, Kajubi R, Mota D, Legac J, Jagannathan P, Havlir D, Kamya M, Dorsey G, Aweeka F, Rosenthal PJ, Savic RM. Modeling Prevention of Malaria and Selection of Drug Resistance with Different Dosing Schedules of Dihydroartemisinin-Piperaquine Preventive Therapy during Pregnancy in Uganda. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01393-18. doi: 10.1128/AAC.01393-18. Print 2019 Feb. |
| 29272443 | Derived | Wallender E, Vucicevic K, Jagannathan P, Huang L, Natureeba P, Kakuru A, Muhindo M, Nakalembe M, Havlir D, Kamya M, Aweeka F, Dorsey G, Rosenthal PJ, Savic RM. Predicting Optimal Dihydroartemisinin-Piperaquine Regimens to Prevent Malaria During Pregnancy for Human Immunodeficiency Virus-Infected Women Receiving Efavirenz. J Infect Dis. 2018 Mar 5;217(6):964-972. doi: 10.1093/infdis/jix660. |
| FG001 | Daily TS + Monthly DP Pregnancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily. Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TS + DP Placebo Pregnancy | Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily. Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines. Placebo |
| BG001 | Daily TS + Monthly DP Pregnancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily. Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Gestational age (cont) | Mean | Standard Deviation | weeks |
| |||||||||||||||
| Gestational age (cat) | Count of Participants | Participants |
| ||||||||||||||||
| Gravidity | Count of Participants | Participants |
| ||||||||||||||||
| Insecticide-treated bednet (ITN) ownership | Count of Participants | Participants |
| ||||||||||||||||
| Household Wealth | Count of Participants | Participants |
| ||||||||||||||||
| Receiving TMP-SMX prophylaxis | Count of Participants | Participants |
| ||||||||||||||||
| Receiving ART | Count of Participants | Participants |
| ||||||||||||||||
| CD4+ T-cell count, cells/mm^3 | Median | Inter-Quartile Range | cells/mm^3 |
| |||||||||||||||
| HIV load below limit of detection | Count of Participants | Participants |
| ||||||||||||||||
| WHO HIV disease stage | WHO clinical staging of HIV/AIDS is defined in the following document: https://www.who.int/hiv/pub/guidelines/clinicalstaging.pdf In brief: Stage 1. Asymptomatic Stage 2. Minor infections or <10% weight loss Stage 3. TB, bacterial infections; systemic symptoms or laboratory values of chronic illness Stage 4. Opportunistic infections or cancers | Count of Participants | Participants |
| |||||||||||||||
| Detection of malaria parasites by LAMP | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Placental Malaria | The primary outcome will be the prevalence of placental malaria based on placental histopathology and dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence of placental infection. | Posted | Count of Participants | Participants | at delivery estimated to be within 10 to 30 weeks of study entry |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Malaria, Pregnant Women | The primary outcome will be the incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. | Posted | Number | Events per person-year | Time at risk will begin following administration of first dose of study drug to delivery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maternal Parasitemia at Delivery by Microscopy and LAMP | Proportion of women with parasitemia detected by microscopy or LAMP at delivery | Out of all 100 enrolled women in each arm: two women in TS+Placebo arm did not have maternal blood specimens collected to analyze; One participant in Daily TS + Monthly DP pregnancy arm did not have blood slide completed for microscopy results but did have blood spot collected for LAMP analysis | Posted | Count of Participants | Participants | At delivery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Placental Parasitemia (Number of Women With Placental Blood Samples Positive for Malaria by Microscopy or PCR) | Proportion of placental blood samples positive for malaria by microscopy or PCR | Out of all 100 enrolled women in each arm: four women in TS+Placebo arm and two women in TS+DP arm did not have placental blood specimens collected to analyze; One participant TS+Placebo arm did not have microscopy results; Only one placental blood specimen was collected for each woman | Posted | Count of Participants | Participants | At delivery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Monthly Routine Visits With Positive Blood Samples for Parasites | Proportion of monthly routine blood samples positive by LAMP for parasites | Posted | Count of Units | visits with positive blood sample | Following administration of first dose of study drug to delivery | visits with positive blood sample | visits with positive blood sample |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite Adverse Birth Outcome (Proportion With Low Birth Weight (<2500 gm), Spontaneous Abortion (<28 Weeks), Stillbirth (Fetal Demise ≥28 Weeks), Congenital Anomaly, or Preterm Delivery (<37 Weeks) | Proportion with low birth weight (<2500 gm), spontaneous abortion (<28 weeks), stillbirth (fetal demise ≥28 weeks), congenital anomaly, or preterm delivery (<37 weeks) | Posted | Count of Participants | Participants | At delivery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Routine Visits Measured Every 8 Weeks During Pregnancy for Which the Participants Had Anemia | Anemia (hemoglobin less than 11g/dL) measured every 8 weeks during pregnancy | Posted | Count of Units | Routine visit done every 8 weeks | Following administration of first dose of study drugs to delivery | Routine visit done every 8 weeks | Routine visit done every 8 weeks |
|
Following administration of first study drug to 6 weeks postpartum
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TS + DP Placebo Pregnancy | Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily. Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines. Placebo | 0 | 100 | 4 | 100 | 92 | 100 |
| EG001 | Daily TS + Monthly DP Pregnancy | Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily. Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants | 0 | 100 | 6 | 100 | 91 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Congenital anomaly | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Systematic Assessment |
| ||
| Cough | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Diarrhea | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Vomiting | General disorders | Systematic Assessment |
| ||
| Anorexia | General disorders | Systematic Assessment |
| ||
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Altered mental status | Psychiatric disorders | Systematic Assessment |
| ||
| Elevated ALT level | Hepatobiliary disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grant Dorsey | UCSF | 415-206-4680 | grant.dorsey@ucsf.edu |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| > 16-20 wk |
|
| > 20 - 24 wk |
|
| > 24 - 28 wk |
|
| 2 pregnancy |
|
| >= 3 pregnancies |
|
| Middle Tertile |
|
| Highest Tertile |
|
| WHO Stage 2 |
|
| WHO Stage 3 |
|
| WHO Stage 4 |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
| visits with positive blood sample |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Routine visit done every 8 weeks |
|
|